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FDA Publishes Complete Response Letters

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FDA publishes redacted versions of over 200 complete response letters issued between 2020 and 2024 in a demonstration of its commi...

Makary Touts Successes in 1st Hundred Days

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FDA commissioner Martin Makary takes a 100-days-in-office victory lap, citing 32 initiatives that he says have been started to Mak...

Merck NDA Accepted for HIV Combination Therapy

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FDA accepts for review a Merck NDA for its investigational once-daily HIV treatment combining doravirine and islatravir.

Senate Committee Advances FDA Budget Bill

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The Senate Committee on Appropriations votes to approve and advance to a floor vote the Fiscal Year 2026 Agriculture, Rural Develo...

FDA Approves Moderna Covid Vaccine sBLA

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FDA approves a Moderna sBLA for its Spikevax Covid-19 vaccine for children aged six months to 11 years old who are at increased ri...

Access to Care House Hearing Set

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The House Energy and Commerce Health Subcommittee schedules a 7/16 hearing on preserving access to timely and affordable care.

Broselow Pediatric Emergency Rainbow Tape Recall

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AirLife recalls certain lots of its Broselow Pediatric Emergency Rainbow Tape because they were manufactured with incorrect inform...

FDA OKs Updated Dosing for Lillys Alzheimer's Drug

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FDA approves an updated dosing schedule for Eli Lillys Alzheimers therapy Kisunla (donanemab-azbt) to reduce the risk of a known s...

CGMP, Other Violations at Dynamic Blending

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FDA warns Vineyard, UT-based Dynamic Blending Specialists about multiple violations in its work as a contract manufacturer of over...

Libby Laboratories CGMP Issues

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FDA warns Berkeley, CA-based Libby Laboratories about CGMP violations in its manufacturing of finished drugs.